Harmonization of C&Q and CSV Initiatives

Posted in Events on January 29th, 2015 by admin – Be the first to comment

“In many instances there is significant overlap between the computerized system validation and the commissioning and qualification activities specially for computerized control systems utilized in the manufacturing, facilities and/or utility processes (e.g. PLC’s, SCADA, DCS). As such, these efforts may be combined under one effort, to ensure proper synchronization and preclude duplication of effort. As a result, a single validation/qualification effort may be performed to produce the required deliverables to achieve compliance while harmonizing work being done even when using different teams. Moreover, the commissioning effort can reduce significantly not only the qualification effort but also the CSV effort, if performed appropriately.


In today’s competitive environment, clear and concise policies and procedures that promote such harmonization effort, regardless of the type of regulated manufacturing process and automation platform, will offer significant value by reducing the cost as well as the time it will take to complete such projects while still meeting the required level of compliance.

Download the flyer here and register below:

“Functional Safety Standards Past, Present and Future”

Posted in Events on November 10th, 2014 by admin – Comments Off

Rochestown Park Hotel, Cork

Wednesday, 26th November 2014, 19.00

Over the last twenty years we have seen many standards applicable to machine and process safety. As technology evolves likewise functional safety standards evolve also.
More recently we have seen updates to major standards like IEC 61508 which will have implications to sector standards like 61511 for Process and 62061 for machinery Safety.

In this presentation, I will discuss how safety standards have evolved for both machinery related applications and process applications and newer hybrid applications.
We will discuss some of the more frequently used machine & process safety standards and take a look to where we can expect these standards to lead us in the near future.

About Brian Maher and Rockwell Automation.

image003Brian Maher has over fifteen years’ experience working in the field of Functional Safety. He was the first Engineer in Ireland to be certified as a functional safety engineer by TÜV Rheinland for machine related safety applications in 2010. He currently works with Rockwell Automation as Senior Commercial Engineer supporting customers and teams across EMEA.




Photos from DLC

Posted in Events on May 21st, 2014 by admin – Comments Off

Photos from MES Conference “Where Next for MES?”

Posted in Events on March 31st, 2014 by admin – Comments Off

Download presentations One Two Three

ISPE GAMP CoP Committee and Speakers

Posted in Events on November 12th, 2013 by admin – Comments Off

From Left: Back Row: Paul Moody – Irish Medicines Board, Annette Keane – LSC, Eddie Ryan – Systematic I.S. Strategies, Colin Taft – J&J LES project Lead, John O’Neill – Senior Director, Quality, Janssen Biologics, Caoimhe Kiely – QUMAS, Kieran Coughlan – LSC, Alan Bateman – Janssen Pharma


Front Row: Sean O’Connor – Zenith Technologies David Twohig, Gilead Sciences, Veronica Power, Mylan Manufacturing Services & Validation Director, Mylan Respiratory, Chris Reid (GAMP Europe President)

Janssen Biologics MES Seminar pictures

Posted in Uncategorized on May 20th, 2012 by admin – Comments Off

Astellas Ireland Kilorglin Plant Plant tour pictures

Posted in Uncategorized on May 20th, 2012 by admin – Comments Off

Pictures from PAT/QbD and Process Validation talk

Posted in Uncategorized on March 31st, 2012 by admin – Comments Off

Pictures from Automation Project Delivery talk

Posted in Events on February 15th, 2012 by admin – Comments Off

Pictures from February 8th 7:30 pm – technical Talk:

Automation Project Delivery

Posted in Uncategorized on February 3rd, 2012 by admin – Comments Off

 19:30 Wednesday 8th February 2012 Rochestown Park Hotel, Cork.

Registration on the night. All are welcome, you don’t need to be an ISA member to attend Feel free to bring a colleague.


Mr Andre Michel Skillpad, Quebec, Canada

Andre Michel has 25 years of successful automation project delivery in a wide variety of industries on projects of all scales. His Experience includes:

Management of preliminary design, detail engineering, construction, commissioning and start-up of projects in many industries

Application of project management methodology, tools and techniques for the management of automation projects

Coordination of multi-discipline teams

Specification, evaluation, selection and purchase of automation equipment

Specification, installation and programming of distributed control system (DCS), PLC, instruments, control elements (including electrical or pneumatic  equipment).

Pharmaceutical experience with FDA regulation, GMP, GAMP 5, CFR 21 Part 11 and Validation

Andre has been a member of ISA since 2001 and has been active at the Section, Dis- trict, Division and Society level of the ISA. Andre is currently the President-Elect of the ISA Montreal Section, where he has held roles of Secretary and Professional Devel- opment Chair. In these roles Andre has developed partnerships with REAI (the organi- zation of Automation Manufacturers in Quebec) and RVA (Rendez Vous of Automa- tion). At a District level Andre has held the role of Leadership Development Chair and participated and presented at the 2011 District Leadership Conference in Toronto and 2010 District Leadership Conference in Montreal. Within the Food and Pharmaceutical Division (FPID) of ISA, Andre has been very active helping to develop and roll out a program of web-based seminars on Pharmaceutical Automation while also being the Newsletter Editor for the last 4 years.